A 48-Week, Randomized, Open-Label Phase 3b Study Comparing the Antiviral Efficacy and Safety of ATV/RTV Plus 3TC with ATV/RTV plus TDF/FTC in HIV-1-Infected, Treatment-Naive Subjects, Followed by a 48-Week Period on ATV/RTV Plus 3TC.

Bristol-Myers Squibb International Corporation0 sites420 target enrollmentStarted: November 20, 2012Last updated: August 8, 2016

Conditions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Active, not recruiting
Sponsor: Bristol-Myers Squibb International Corporation
Enrollment: 420

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional clinical trial of medicinal product

Eligibility Criteria

Sex: All

Inclusion Criteria

•1) Signed Written Informed Consent
•a) Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the trial.
•b) A freely given PK sub-study consent form must be obtained from the subset of
•subjects participating in the intensive PK sub-study.
•2) Target Population
•a) Treatment-naive HIV-1-infected subjects (< 48 hours of any ARV is allowed)
•b) Subjects who have an HIV-1 RNA level = 1000 c/mL at screening
•c) Subjects who have a CD4+ cell count > 100 cells/mm3.
•3) Age and Reproductive Status
•a) Men and women, 18 years of age or older (or minimum age as determined by local regulatory or legal requirements)
•b) Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 2. For a teratogenic study drug and/or when there is insufficient information to assess teratogenicity (preclinical studies have not been done), a highly effective method(s) of contraception (failure rate of less than 1% per year) is required. The individual methods of contraception should be determined in consultation with the investigator. WOCBP must follow instructions for birth control for a period of 30 days after the last dose of investigational product.
•c) Women must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of investigational product.
•d) Women must not be breastfeeding
•e) Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men that are sexually active with WOCBP must follow instructions for birth control for a period of 90 days aftert the last dose of investigational product.
•f) Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile--see Section 3.3.3 for the definition of WOCBP) and azoospermic men do not require contraception.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 400
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

•1) Target Disease Exceptions
•a) Subjects who have an HIV-1 RNA level = 500,000 c/mL at screening
•b) Screening HIV genotype showing resistance to any component of the study regimen (ATV, RTV, 3TC, TDF/FTC) or primary resistance mutations to HIV protease inhibitors (see Appendix 4)
•c) Previously documented HIV-2 infection
•2) Medical History and Concurrent Diseases
•a) Acute or chronic hepatitis B virus (HBV)
•b) Acute hepatitis C virus (HCV) co-infection.
•Note: Chronic co-infection with hepatitis C is not an exclusion criteria. Subjects with acute hepatitis C may have the option to be screened after the event has evolved into a chronic infection.
•c) Presence of a newly diagnosed HIV-related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment. Subjects on stable maintenance therapy for an opportunistic infection may be enrolled
•d) Primary HIV infection
•e) History or current cardiac disease, defined by presence of arrhythmias, ischemic disease, or a conduction abnormality including left bundle branch block (LBB) or left anterior fascicular block (LAFB), 2nd- or 3rd-degree atrioventricular block (AVB), or any cardiac abnormality deemed clinically significant by the investigator. In addition, the following ECG findings are exclusionary:
•i) PR Interval > 260 msec (severe 1st degree AV Block)
•ii) QRS Interval > 120 msec
•f) Moderate-to-severe hepatic insufficiency
•g) Obstructive liver disease
•h) Recent therapy with agents having significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or the expected need for such therapy at the time of enrollment, or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4
•i) Concomitant administration of a proton pump inhibitor (PPI) or H2 blocker or any other drug with potential interaction with the investigational productsj) Life expectancy < 1 year according to the judgment of the investigator
•k) Active alcohol or substance use sufficient, in the investigator’s opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis
•l) History or ongoing psychiatry disorder
•3) Physical and Laboratory Test Findings
•a) Screening laboratory analysis showing any of the following abnormal laboratory
•i) Grade IV glucose
•ii) Grade IV electrolytes
•iii) Grade IV transaminases
•iv) Grade IV hematology
•v) Calculated creatinine clearance < 60 mL/min as estimated by the Cockcroft- Gault equation.
•4) Allergies and Adverse Drug Reaction
•a) Hypersensitivity to any component of the study drug formulations.
•5) Sex and Reproductive Status
•a) Women with a positive pregnancy test on enrollment or prior to study drug administration
•6) Other Exclusion Criteria
•a) Prisoners or subjects who are involuntarily incarcerated
•b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness (eg, infectious disease)

Investigators

Sponsor

Bristol-Myers Squibb International Corporation

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